AN0025 and Chemoradiotherapy Combination in Esophageal Cancer

NCT05191667 | Suspended Phase 1

• 1 other identifier: AN0025S0104
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter, phase Ib study to evaluate the safety, tolerability, and preliminary efficacy of AN0025 in combination with chemoradiotherapy (CRT) in patients with locally advanced/locally recurrent esophageal cancer.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with Dose Limiting Toxicities (DLTs)

  DLTs are defined as study drug-related toxicities graded using Common Terminology Criteria for Adverse events of the National Cancer Institute (NCI CTCAE) V5.0 occurring during DLT period (the first 4 weeks of AN0025 administration in combination with dCRT)

  4 weeks

Secondary Outcomes (5)

• Complete response rate (CRR)

  2 years

• Objective response rate (ORR)

  2 years

• Disease control rate (DCR)

  2 years

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

Patients with unresectable locally advanced/locally recurrent esophageal cancer

EXPERIMENTAL

Patients will receive AN0025 orally once daily (QD) and chemoradiotherapy followed by the maintenance of AN0025

Drug: AN0025

Interventions

AN0025 DRUG

250 mg or 500 mg Q.D., oral administration

Also known as: Paclitaxel, Carboplatin, Radiotherapy

Patients with unresectable locally advanced/locally recurrent esophageal cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with histologically- and/or cytologically-confirmed locally advanced/locally recurrent squamous cell carcinoma or adenocarcinoma of the esophagus or of the esophagogastric junction (EGJ).
• Male or female, age≥18 years at the time of informed consent.
• Have provided signed informed consent for the trial and are willing to comply with all aspects of the protocol

You may not qualify if:

• With a history of another primary malignancy within the past 2 years, with the exception of basal or squamous cell skin cancer, or carcinoma in situ of the cervix or breast that has undergone potentially curative therapy.
• Participants with known Hepatitis B or C infections, or known to be positive for Hepatitis B antigen (HBsAg)/ Hepatitis B virus (HBV) DNA or Hepatitis C antibody (HepC Ab)/ Hepatitis C virus (HCV) RNA. Active Hepatitis B is defined by a known positive HepB Ab result and known quantitative HBV DNA results greater than the lower limits of detection of the assay. Active Hepatitis C is defined by a known positive HepC Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
• Participants with known human immunodeficiency virus (HIV) infection (positive for HIV-1/2 antibody) or syphilis infection (positive for syphilis spiral antibody).
• Major surgery or severe trauma within 4 weeks before the first dose of study drug. Note: If participant received major surgery, they must have recovered adequately from surgery and the toxicity and/or complications requiring the intervention prior to starting study treatment.
• Have received prior systemic anti-cancer therapy including chemotherapy, target therapy, immunotherapy, anti-cancer traditional Chinese medicine, and other investigational oncology agents within 4 weeks or 5 half-lives, whichever is shorter. Participants who have entered the follow-up phase of an investigational study may participate as long as it has been at least 4 weeks (or 5 half-lives, whichever is shorter) after the last dose of the previous investigational agent.
• Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or returned to baseline. Participants with ≤ Grade 2 neuropathy or alopecia (per CTCAE v5.0) may be eligible.
• Are currently participating in a study of an investigational device within 4 prior to the first dose of study treatment.
• Have uncontrolled tumor-related pain.
• Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
• Have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

Sponsors & Collaborators

• Adlai Nortye Biopharma Co., Ltd.: lead

Study Sites (1)

Jianming Xu

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Paclitaxel; Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Therapeutics

Study Officials

• Jianming Xu, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: January 13, 2022
• Study Start: January 18, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)